BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19476864 · Received June 6, 2024

    Report

    Report Number
    3006630150-2024-03652
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    April 17, 2024
    Report Date
    June 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: SC-2218-50 MODEL: M365SC2218500 SERIAL: (B)(6). BATCH: 7110865.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED DEVICES WERE NOT RETURNED AS THE HOSPITAL DISPOSED OF THE EXPLANTED ITEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5694 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7110683 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention